Title: An open-label, phase 1b-2 study of elacestrant, in combination with onapristone in patients with estrogen receptor-positive, progesterone receptor-positive, HER2-negative advanced or metastatic breast cancer (ELONA)
Responsible Party: Context Therapeutics, Inc.
Description: Researchers are conducting a phase 1b/2 study to test elacestrant plus onapristone in patients with estrogen receptor (ER)-positive, progesterone receptor (PR)-positive, HER2-negative, advanced or metastatic breast cancer.
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Patients will receive elacestrant at 200 mg, 300 mg, or 400 mg orally once daily during each 28-day treatment cycle. They will receive onapristone at 40 mg or 50 mg twice daily orally during each cycle.
The primary outcome in phase 1 is the recommended phase 2 dose. The primary outcome in phase 2 is the efficacy of the combination, as measured by the objective response rate.
Secondary outcomes include adverse events, duration of response, progression-free survival, overall survival, and more.
To be eligible for this study, patients must be 18 years of age or older and have a histologically or cytologically confirmed diagnosis of ER-positive, PR-positive, HER2-negative breast cancer. They must have had prior treatment with an aromatase inhibitor or fulvestrant plus a CDK4/6 inhibitor in the metastatic setting or in the adjuvant setting if within 12 months of the last dose of adjuvant therapy.
For a complete list of eligibility criteria, please see the reference.
Status: Recruiting
This study is sponsored by Context Therapeutics, Inc.
Reference
ClinicalTrials.gov. Study of elacestrant in combination with onapristone in patients with advanced or metastatic breast cancer (ELONA). NCT05618613. Accessed December 13, 2022.
